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Regulatory Affairs Consultant Pediatric
Eingestellt von Harvey Nash IT Recruitment Belgium
Gesuchte Skills: Consultant, Opal
Projektbeschreibung
One of our clients, a multinational company in the pharmaceutical industry currently requires a Regulatory Affairs Consultant Pediatric
Start: ASAP
Lenght: min. until 31/12/14
Location: South of Brussels
FUNCTION DESCRIPTION:
Title: Regulatory Affairs consultant, Global Regulatory Affairs, Neisseria/Hib projects
Description:
Involved in the company's regulatory activities related to existing products (both in Europe and outside of Europe).
Ensure the planning/dispatch/submission/follow up of data packages due to Regulatory Authorities for Neisseria/Hib vaccines (Variations, Commitments, Questions & Answers, PSURs, Risk Management Plans(RMPs), Renewals, Article 46, Updated files, etc.)
KEY RESPONSIBILITIES:
* Organises the preparation, submission and follow-up of MAA and of regulatory life cycle activities on products from the Neisseria/HIb vaccines portfolio in Europe and Worldwide. Ensures that licences forthe Neisseria-Hib products are maintained in compliance with regulatory requirements worldwide.
* Coordinate, prioritize and plan all the registration activities forthe products within area of responsibility. Ensure these plans areupdated and communicated appropriately. If needed, interact with Regulatory Operation for this activity (for OPAL, CARS)
* Coordinate and interact with Clinical RA/labelling/Safety/Epi/Technical RA/Regulatory Operations for the preparation of the documents part of the regulatory data packages in order to meet the submission timelines.
* Follows up all commitments for the products attributed
* Organises and archives registration files and regulatorycorrespondence with the LOCs in the appropriate systems.
* Ensures that all the aspects of the product safety are closely monitored and fulfil the pharmacovigilance/regulatory
* Exhibit a solid understanding of the global regulatory legislation, particularly relating to administrative and procedural aspects.
* Maintain close contacts with the Local Operating Company's to ensure shared objectives are achieved.
* Identify key issues on resource or registration activities that could prevent achieving objectives or that could lead to supply issues and pro-actively propose solutions to management to solve the problem.
* Participates in relevant internal meetings such as the Regulatory Project Team meetings, Implementation Committees.
The execution of these Regulatory activities need to be performed in line with the global regulatory legislation and guidances.
Necessary trainings to learn internal procedures and regulatory systems/databases need to be followed.
PREREQUISITES:
Education:
University degree (preferably biological/chemical/pharmacist)
Knowledge: Some EU regulations (centralized or mutual recognition or national procedures)/English fluent - oral and written/IT tools
Skills:
Team spirit, Flexibility and accountability, very well organized, good relationships, able to work in multi-cultural environment
Tags: Regulatory, RA, Clinical, submission, pharmaceutical, life cycle
Start: ASAP
Lenght: min. until 31/12/14
Location: South of Brussels
FUNCTION DESCRIPTION:
Title: Regulatory Affairs consultant, Global Regulatory Affairs, Neisseria/Hib projects
Description:
Involved in the company's regulatory activities related to existing products (both in Europe and outside of Europe).
Ensure the planning/dispatch/submission/follow up of data packages due to Regulatory Authorities for Neisseria/Hib vaccines (Variations, Commitments, Questions & Answers, PSURs, Risk Management Plans(RMPs), Renewals, Article 46, Updated files, etc.)
KEY RESPONSIBILITIES:
* Organises the preparation, submission and follow-up of MAA and of regulatory life cycle activities on products from the Neisseria/HIb vaccines portfolio in Europe and Worldwide. Ensures that licences forthe Neisseria-Hib products are maintained in compliance with regulatory requirements worldwide.
* Coordinate, prioritize and plan all the registration activities forthe products within area of responsibility. Ensure these plans areupdated and communicated appropriately. If needed, interact with Regulatory Operation for this activity (for OPAL, CARS)
* Coordinate and interact with Clinical RA/labelling/Safety/Epi/Technical RA/Regulatory Operations for the preparation of the documents part of the regulatory data packages in order to meet the submission timelines.
* Follows up all commitments for the products attributed
* Organises and archives registration files and regulatorycorrespondence with the LOCs in the appropriate systems.
* Ensures that all the aspects of the product safety are closely monitored and fulfil the pharmacovigilance/regulatory
* Exhibit a solid understanding of the global regulatory legislation, particularly relating to administrative and procedural aspects.
* Maintain close contacts with the Local Operating Company's to ensure shared objectives are achieved.
* Identify key issues on resource or registration activities that could prevent achieving objectives or that could lead to supply issues and pro-actively propose solutions to management to solve the problem.
* Participates in relevant internal meetings such as the Regulatory Project Team meetings, Implementation Committees.
The execution of these Regulatory activities need to be performed in line with the global regulatory legislation and guidances.
Necessary trainings to learn internal procedures and regulatory systems/databases need to be followed.
PREREQUISITES:
Education:
University degree (preferably biological/chemical/pharmacist)
Knowledge: Some EU regulations (centralized or mutual recognition or national procedures)/English fluent - oral and written/IT tools
Skills:
Team spirit, Flexibility and accountability, very well organized, good relationships, able to work in multi-cultural environment
Tags: Regulatory, RA, Clinical, submission, pharmaceutical, life cycle
Projektdetails
Geforderte Qualifikationen
-
Kategorie:
IT Entwicklung, Organisation/Management